MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT265

Device Problem Decrease in Pressure (1490)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) representative that the expiratory limb of an rt265 infant dual-heated evaqua2 breathing circuit was damaged after seven days of use.They further reported that the bear cub ventilator alarmed for low pressure.No patient consequence was reported.

Manufacturer Narrative

(b)(6).Method: the complaint rt265 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4).It was visually inspected and the inspiratory and expiratory heater wires were resistance tested with a calibrated multimeter.Results: visual inspection of the expiratory limb revealed cracks on both the distal and proximal connectors.The expiratory limb was cracked approximately 10 - 20 mm from the proximal connector.It was also slightly discoloured and dark marks were noted approximately 90mm from the distal connector.Visual inspection of the inspiratory limb revealed damage to the tube near the proximal connector.The resistance test showed that both the inspiratory and expiratory heater wires were within specification.The hospital provided further information to a fph representative which indicates that the returned circuit was sterilized and reused on multiple patients.The hospital further informed us that the returned circuit was actually used for eight days and not seven.The hospital also informed us that it is their standard protocol to sterilize and reuse single use breathing circuits.Conclusion: the rt265 infant dual heated evaqua2 breathing circuit is a single use device that is intended to be used for a maximum of seven days.A caution tag is attached to the inspiratory limb of the rt265 warns the user of the seven day intended use.Furthermore, the user instructions that accompany the rt265 state: "this product is intended to be used for a maximum of 7 days." "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death." since the reported incident a fph representative has been in contact with the hospital staff.We are also in the process of formally writing to them to reiterate our user instructions that fph single use breathing circuits are not to be cleaned or reused.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4062173
• MDR Text Key: 21238823
• Report Number: 9611451-2014-00748
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2014
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BEAR CUB VENTILATOR